Vyloy (zolbetuximab or zolbetuximab-clzb) is a targeted cancer medication. It's used to treat adults with certain advanced or metastatic stomach cancer and gastroesophageal junction (GEJ) cancer. These cancers must be HER2‑negative and claudin 18.2‑positive. Vyloy (zolbetuximab) is a monoclonal antibody given as an infusion through a vein at a clinic. It's given every 2 or 3 weeks with certain chemotherapy medications. Side effects include nausea, vomiting, and low appetite.
Vyloy (zolbetuximab) is a claudin 18.2 (CLDN18.2)–directed monoclonal antibody. It finds the CLDN18.2 protein on stomach and GEJ cancer cells. This protein is often found in higher amounts on the cells of these types of cancers.
Once the medication finds the cancer cells, it flags these cells for your immune system to attack and kill. This can slow or stop the cancer from growing.
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Note: Vyloy (zolbetuximab) is taken with certain chemotherapy medications. Your side effects might be different depending on your chemotherapy plan.
Contact your healthcare provider immediately if you experience any of the following.
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Vyloy (zolbetuximab) is given as an infusion through a vein. This is called an intravenous, or IV, infusion. A healthcare professional will help give the infusion.
Your first infusion of Vyloy (zolbetuximab) will take at least 3.5 hours. The infusions after that might might take a little less time. But your nurse might need to slow down or pause your infusion if you have side effects like nausea and infusion reactions. This can make your infusion take longer. Also, you'll need to stay at the clinic for at least 2 hours afterward so the care team can watch for any other reactions. Talk to your care team about what to expect during your Vyloy (zolbetuximab) infusions.
You need to go to an infusion center or clinic to get Vyloy (zolbetuximab). This is because a nurse will help give the medication as an infusion through a vein. Vyloy (zolbetuximab) can cause nausea, vomiting, and infusion reactions. So it's safest to get it at a clinic where the care team can help if needed. Talk to your care team about where to receive your Vyloy (zolbetuximab) infusions.
The FDA approved Vyloy (zolbetuximab) in October 2024. It's used with certain chemotherapy medications. Vyloy (zolbetuximab) is the first treatment for HER2‑negative stomach cancers and gastroesophageal junction (GEJ) cancers that are claudin 18.2‑positive.
If you can become pregnant, talk to your oncologist. It's not clear if this medication can harm an unborn baby. But many cancer medications, including the other chemotherapies used with Vyloy (zolbetuximab), have this risk. Your oncologist can help explain the risks and benefits of treatment. They can also discuss family planning and reliable birth control. Call your care team right away if you get pregnant during treatment.
Don’t breastfeed while taking Vyloy (zolbetuximab) and for 8 months after your last dose. We don't exactly know if the medication can pass into breast milk and can cause serious side effects in your baby. Talk to your care team or a lactation consultant about other ways to feed your baby.
Vyloy (zolbetuximab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Allergic reactions can happen with Vyloy (zolbetuximab). Some reactions can be serious or even life-threatening, including anaphylaxis and infusion reactions. Your care team will watch closely for these reactions during the infusion and for at least 2 hours after.
If a reaction happens during your infusion, your care team can pause it and help treat your symptoms. Once you feel better, they might restart it at a slower speed. Before future infusions, your care team will give you an antihistamine to help prevent another reaction. If the reaction is severe, you might have to stop Vyloy (zolbetuximab) completely.
Watch for a cough that doesn't go away, wheezing, throat tightness, a change in your voice, or trouble breathing. Other symptoms include hives, fever, chills, nausea, vomiting, and stomach, chest, or back pain. If you notice any of these during or after your infusion, tell your nurse right away or get medical help.
Vyloy (zolbetuximab) can cause nausea and vomiting, which can sometimes be severe. These side effects are very common during the first treatment cycle.
Before each Vyloy (zolbetuximab) infusion, you’ll get anti‑nausea medication. Your oncologist might also give you anti-nausea medications to use at home if you need them.
Your care team can help manage nausea and vomiting. If this happens during your infusion, the nurse can pause it to help. They might also give more anti-nausea medication or IV fluids. If it's severe, your oncologist might decide to stop Vyloy (zolbetuximab) altogether.
Tell your care team right away if you feel very nauseous, can’t keep fluids down, or vomit a lot. Also call your care team if you notice signs of dehydration from these side effects, like dizziness, exhaustion, or dark urine.
Vyloy (zolbetuximab) is given as an infusion through a vein, or an intravenous (IV) infusion. It's usually given with other chemotherapy. A nurse will help infuse the medication at a medical center or clinic.
Your oncologist will determine your dose based on your body surface area (BSA). They'll take your height and weight into account.